Sirolimus-eluting vs Zotarolimus-eluting Stents for Chronic Total Coronary Occlusions

June 3, 2015 updated by: Dr. M.J. Suttorp, R&D Cardiologie

A Randomized Comparison of Sirolimus-eluting Stent Implantation With Zotarolimus-eluting Stent Implantation for the Treatment of Chronic Total Coronary Occlusions. The PRISON III Trial.

Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this prospective randomized trial, sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is in-segment late luminal loss at 8 month angiographic follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) was traditionally limited by high restenosis rates. Coronary stenting using bare metal stents significantly decreases restenosis in CTO compared to balloon angioplasty alone, but restenosis rates still reach 32-55%. In 200 patients with CTO, randomized in the PRISON I study we demonstrated a restenosis rate of 22% after bare metal stent (BMS) implantation as compared with 33% after conventional balloon angioplasty. During the past few years, sirolimus (rapamycin), a cytostatic macrocyclic lactone with anti-inflammatory and antiproliferative properties, delivered from a polymer-encapsulated stent was shown to almost eliminate the risk of restenosis in selected groups of patients. The drug zotarolimus (ABT-578), a sirolimus analogue, is designed to inhibit the cellular process that leads to restenosis. In the PRISON II study we have randomized 200 patients with CTO to either BMS implantation or sirolimus-eluting stent implantation and we demonstrated a reduction of in-stent binary restenosis from 36% to 7% and in-segment binary restenosis rates from 41% to 11% in favour of the sirolimus eluting stent. However, no data are available on direct comparison of the clinical efficacy, safety, and angiographic outcome of particular drug-eluting stents in patients with CTO and there may be differences between various drug-eluting stents. The PRISON III study is designed to address this issue and provide information about two different drug-eluting stents. It is a prospective randomized, single blinded trial comparing the relative safety, clinical efficacy and angiographic outcomes of sirolimus and zotarolimus-eluting stents in patients undergoing successful recanalization of CTO.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • AZ Middelheim
  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • AMC
      • Amsterdam, Netherlands, 1090HM
        • Onze Lieve Vrouwe Gasthuis
      • Eindhoven, Netherlands, 5602ZA
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands, 3435CM
        • St Antonius hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  • the estimated duration of the occlusion is at least 2 weeks.
  • signs of ischemia related to the occluded coronary artery.
  • successful recanalization of the occluded artery is achieved.
  • reference diameter is > 2.5 mm.
  • written informed consent obtained.

EXCLUSION CRITERIA

  • primary or rescue PCI for acute myocardial infarction
  • the lesion could not be crossed.
  • lesions with complex anatomy making successful stent deployment unlikely.
  • the guide wire is not in the true lumen distal to the occlusion.
  • Sirolimus or zotarolimus allergy
  • venous or arterial bypass grafts
  • pregnant or nursing women.
  • participation in an other trial.
  • factors making long-term follow-up difficult or unlikely.
  • life expectancy <1 year.
  • contraindications for ASA or Clopidogrel or heparin.
  • use of coumadins that could not be stopped before the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zotarolimus eluting stent
Device: sirolimus-eluting stent, zotarolimus-eluting stent
PCI in chronically occluded coronary artery
ACTIVE_COMPARATOR: Sirolimus eluting stent
Device: sirolimus-eluting stent, zotarolimus-eluting stent
PCI in chronically occluded coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-segment late luminal loss at 8 months as assessed by an independent angiographic core lab.
Time Frame: 8 month
8 month

Secondary Outcome Measures

Outcome Measure
Time Frame
In-stent late luminal loss
Time Frame: 8 month
8 month
In-stent and in-segment binary restenosis rate
Time Frame: 8 month
8 month
In-stent and in-segment MLD
Time Frame: 8 month
8 month
Percentage diameter stenosis
Time Frame: 8 month
8 month
A composite of major adverse cardiac events (MACE: death, myocardial infarction and clinically driven target lesion revascularization)
Time Frame: 8 month
8 month
Stent thrombosis (acute, <1day; subacute, 1 to 30 days; and late, >30 days)
Time Frame: 30 days
30 days
Target vessel failure up to 5 year of clinical follow-up.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R&D Cardiologie

Collaborators

Cordis Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

January 29, 2007

First Submitted That Met QC Criteria

January 29, 2007

First Posted (ESTIMATE)

January 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDC-2006-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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